In December, the European Commission proposed far-reaching changes to EU pharmaceutical legislation, including:
- The first systematic overhaul of the EU’s pharmacovigilance framework since 1965
- New rules clarifying what information about prescription medicines pharmaceutical companies can provide to the general public
- The introduction of new legislative provisions to combat counterfeiting of medicinal products
If adopted, the proposals will have a major impact on how pharmaceutical companies do business in Europe. Pharma companies will need to update their pharmacovigilance processes related to roles and responsibilities, adverse drug reaction case reports, periodic safety update reports and much more. Companies will also want to review their policies for disseminating information about medicines to ensure compliance with the new EU rules and to harmonize the information they provide in different EU member states.
Additionally, all supply chain operators will need to comply with stricter requirements aimed at combating counterfeiting, including new provisions regarding product safety features, controls and audits of suppliers, and additional inspections – some of which may hamper trade.
The proposals provide for a broad range of amendments to Directive 2001/83/EC on medicinal products for human use, and Regulation (EC) No. 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (EMEA). The suggested changes will now be sent to the Council and the European Parliament for review, amendment and adoption.
The Commission also adopted a vision for the European pharmaceutical sector that outlines initiatives the Commission will pursue in the near future. These include further improvement of a single and sustainable market in pharmaceuticals, taking on the opportunities and challenges of globalization, and making science deliver for European patients.
Sidley is proud to co-sponsor this FDC-Windhover webinar.
Wednesday, Jan. 21, 2009
11 am Eastern | 8 am Pacific | 4 pm WET | 5 pm CET